An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy

Terminated

• Conditions: Children With Cerebral Palsy

• Registration Number: NCT01684254
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

The present project will focus on evaluating the technical efficacy of the in-shoe gait monitoring device (ActiveGait) through laboratory based biomechanical gait assessments of children who exhibit gait deviations due to CP or idiopathic toe walking wearing the device.

Detailed Description

The investigators on this protocol intend to develop the device and rely on it to propose a Toe Walk Severity (TWS) index, a novel outcome measure for quantifying changes in severity of toe walking over time and for assessing the outcome of surgical and non-surgical interventions.

Tasks include:

A.Validate data acquisition measurements in laboratory setting compared to gold-standard video analysis and field (outside of laboratory).

B.Develop multi-stage classification algorithm from subset of laboratory and field data.

C.Validate classification algorithm against random subsets of laboratory and field data.

D.Explore the development of a Toe Walking Severity (TWS) index from available biomechanical and ActiveGait data for different ambulatory conditions.

E.Perform longitudinal study of the childhood toe walking population including both laboratory analysis and at-home monitoring using ActiveGait technology.

F.Analyze statistically the sensitivity and specificity of the TWS index compared to clinical observations. Gather evidence that the TWS index provides a means to track changes in severity of toe walking over time.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• able to ambulate 50 feet on level ground without the assistance of a person
• able to ambulate on ramps and stairs without the assistance of a person
• demonstrate a toe-walking pattern at the time of enrollment
• medically stable
• able to understand directions and follow simple instructions

Exclusion Criteria

• any cardiopulmonary, orthopedic, and neurological conditions other than CP that would prevent them from performing the motor tasks of interest

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toe Walking Severity (TWS) index	1 day	Measure for quantifying changes in severity of toe walking over time based on Center of Pressure trajectories computed by the sensorized insole

Secondary Outcome Measures

Name	Time	Method
Edinburgh Visual Scale (EVS) score	1 day	Clinical measure of severity of gait deviation

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States